This invention relates generally to the field of cataract surgery and more particularly to an intraoperative pressure monitoring method for use with a phacoemulsification system.
The human eye in its simplest terms functions to provide vision by transmitting light through a clear outer portion called the cornea, and focusing the image by way of the lens onto the retina. The quality of the focused image depends on many factors including the size and shape of the eye, and the transparency of the cornea and lens.
When age or disease causes the lens to become less transparent, vision deteriorates because of the diminished light which can be transmitted to the retina. This deficiency in the lens of the eye is medically known as a cataract. An accepted treatment for this condition is surgical removal of the lens and replacement of the lens function by an artificial intraocular lens (IOL).
In the United States, the majority of cataractous lenses are removed by a surgical technique called phacoemulsification. During this procedure, a thin phacoemulsification cutting tip is inserted into the diseased lens and vibrated ultrasonically. The vibrating cutting tip liquefies or emulsifies the lens so that the lens may be aspirated out of the eye. The diseased lens, once removed, is replaced by an artificial lens.
A typical ultrasonic surgical device suitable for ophthalmic procedures consists of an ultrasonically driven handpiece, an attached cutting tip, and irrigating sleeve and an electronic control console. The handpiece assembly is attached to the control console by an electric cable and flexible tubings. Through the electric cable, the console varies the power level transmitted by the handpiece to the attached cutting tip and the flexible tubings supply irrigation fluid to and draw aspiration fluid from the eye through the handpiece assembly.
The operative part of the handpiece is a centrally located, hollow resonating bar or horn directly attached to a set of piezoelectric crystals. The crystals supply the required ultrasonic vibration needed to drive both the horn and the attached cutting tip during phacoemulsification and are controlled by the console. The crystal/horn assembly is suspended within the hollow body or shell of the handpiece by flexible mountings. The handpiece body terminates in a reduced diameter portion or nosecone at the body's distal end. The nosecone is externally threaded to accept the irrigation sleeve. Likewise, the horn bore is internally threaded at its distal end to receive the external threads of the cutting tip. The irrigation sleeve also has an internally threaded bore that is screwed onto the external threads of the nosecone. The cutting tip is adjusted so that the tip projects only a predetermined amount past the open end of the irrigating sleeve.
In use, the ends of the cutting tip and irrigating sleeve are inserted into a small incision of predetermined width in the cornea, sclera, or other location. The cutting tip is ultrasonically vibrated along its longitudinal axis within the irrigating sleeve by the crystal-driven ultrasonic horn, thereby emulsifying the selected tissue in situ. The hollow bore of the cutting tip communicates with the bore in the horn that in turn communicates with the aspiration line from the handpiece to the console. A reduced pressure or vacuum source in the console draws or aspirates the emulsified tissue from the eye through the open end of the cutting tip, the cutting tip and horn bores and the aspiration line and into a collection device. The aspiration of emulsified tissue is aided by a saline flushing solution or irrigant that is injected into the surgical site through the small annular gap between the inside surface of the irrigating sleeve and the cutting tip.
During cataract surgery, it is necessary to control the intraocular pressure (“IOP”) within the eye. Lack of control over the IOP may impair the effectiveness or ease of the procedure, and in certain cases may result in damage to tissue, such are the result of a collapse of the eyeball with concomitant tissue damage. Conversely, over-pressuring the intraocular region may also result in damage to the sensitive retinal, optic nerve, or corneal tissue. However, it is occasionally desirable to apply controlled high pressure for a brief time period, for example, to staunch bleeding in the intraocular region.
One method of controlling pressure within the eye during surgery is disclosed in U.S. Pat. No. 4,041,947 to Weiss, et al. That patent discloses the use of limiting valves external to the eye on the infusion and aspiration lines. These limiting valves are designed to provide pressure relief if either the pressure in the infusion line exceeds a high limit, or if the pressure in the aspiration line exceeds a low limit. This device does provide some ability to maintain pressure within a predetermined range of values, but does not allow the surgeon to accurately know or set the IOP.
IOP can be directly measured by insertion of a pressure transducer into the eye. U.S. Pat. Nos. 4,548,205, 4,722,350, and 4,841,984 to Armeniades, et al., disclose direct measurement and control of the IOP. A pressure transducer is inserted into the eye as an independent tool or integrated into the cutting tool. Alternatively, a pressure transducer can be integrated into a separate tool that provides infusion or aspiration. However, there are several problems with tools which provide direct measurement of the IOP. If the pressure transducer is incorporated into the invasive portion of a tool, the tool must be made larger in diameter than is necessary to perform the actual surgery. This approach requires a correspondingly larger incision in the eyeball for tool insertion. Further, integration of a pressure transducer into another tool creates inaccuracies in the pressure readings caused by the proximity of the transducer to the operating infusion line, aspiration line, or surgical tool.
One solution to the size problem is to design a tool with a channel which is inserted into the eye and which provides fluid communication with a pressure transducer outside of the eye. However, this design suffers from the same accuracy problems detailed above, as well as problems caused by debris from the operation clogging the channel. This accuracy problem can be overcome by providing a separate tool that only contains a pressure transducer for insertion into the eye away from the operating tools. However, this approach is disfavored because it requires another incision into the eye.
Currently, no commercial surgical console provides any direct indication of the IOP level. Users control IOP by adjusting the irrigation source pressure (bottle height) to the level appropriate for combination of the settings used (aspiration rate, vacuum limit, tip, sleeve, etc.). Users evaluate and establish a certain IOP level based on their experience with a particular instrument. Although one commercially available surgical instrument, the INFINITI® Vision System, has an irrigation pressure sensor (“IPS”) that can be used as an indirect indicator of the IOP quality, the variables downstream of the sensor can distort the interpretation of the IPS reading. For example, given identical instrument setting, a more restrictive irrigation sleeve will result in a higher IPS reading, which can be misinterpreted as indicating a higher IOP level, whereas in reality the IOP will be lower than expected.
Therefore, a need continues to exist for a method of measuring IOP during ophthalmic surgery.